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Chapter

3 Food

Parts 3-1 CHARACTERISTICS 3-2 SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS AND RECORDS

3-3 PROTECTION FROM CONTAMINATION AFTER RECEIVING 3-4 DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN 3-5 LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH

CONCERN 3-6 FOOD IDENTITY, PRESENTATION, AND ON-PREMISES

LABELING 3-7 CONTAMINATED FOOD 3-8 SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS

3-1 CHARACTERISTICS Subparts 3-101 Condition

Condition 3-101.11 Safe, Unadulterated, and Honestly Presented.*

FOOD shall be safe, unADULTERATED, and, as specified under § 3-601.12, honestly presented.

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3-2 SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS AND RECORDS Subparts 3-201 Sources 3-202 Specifications for Receiving 3-203 Original Containers and Records

Sources 3-201.11 Compliance with Food Law.* (A) FOOD shall be obtained from sources that comply with LAW. (B) FOOD prepared in a private home may not be used or

offered for human consumption in a FOOD ESTABLISHMENT. (C) PACKAGED FOOD shall be labeled as specified in LAW,

including 21 CFR 101 FOOD Labeling, 9 CFR 317 Labeling, Marking Devices, and Containers, and 9 CFR 381 Subpart N Labeling and Containers, and as specified under §§ 3-202.17 and 3-202.18.

(D) Fish, other than MOLLUSCAN SHELLFISH, that are intended for

consumption in their raw form and allowed as specified in Subparagraph 3-401.11(C)(1) may be offered for sale or service if they are obtained from a supplier that freezes the FISH as specified under § 3-402.11; or frozen on the PREMISES as specified under § 3-402.11 and records are retained as specified under § 3-402.12.

(E) WHOLE-MUSCLE, INTACT BEEF steaks that are intended for

consumption in an undercooked form without a CONSUMER advisory as specified in ¶ 3-401.11(C) shall be:

(1) Obtained from a FOOD PROCESSING PLANT that, upon

request by the purchaser, packages the steaks and labels them, to indicate that the steaks meet the definition of WHOLE-MUSCLE, INTACT BEEF, or

(2) Deemed acceptable by the REGULATORY AUTHORITY

based on other evidence, such as written buyer specifications or invoices, that indicates that the steaks meet the definition of WHOLE-MUSCLE, INTACT BEEF, and

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(3) If individually cut in a FOOD ESTABLISHMENT: (a) Cut from WHOLE-MUSCLE INTACT BEEF that is labeled by

a FOOD PROCESSING PLANT as specified in Subparagraph (E)(1) of this section or identified as specified in Subparagraph (E)(2) of this section,

(b) Prepared so they remain intact, and (c) If PACKAGED for undercooking in a FOOD

ESTABLISHMENT, labeled as specified in Subparagraph (E)(1) of this section or identified as specified in (E)(2) of this section.

(F) MEAT and POULTRY that is not a READY-TO-EAT FOOD and is in

a PACKAGED form when it is offered for sale or otherwise offered for consumption, shall be labeled to include safe handling instructions as specified in LAW, including 9 CFR 317.2(l) and 9 CFR 381.125(b).

(G) EGGS that have not been specifically treated to destroy all

viable Salmonellae shall be labeled to include safe handling instructions as specified in LAW, including 21 CFR 101.17(h).

3-201.12 Food in a Hermetically Sealed Container.* FOOD in a HERMETICALLY SEALED CONTAINER shall be obtained

from a FOOD PROCESSING PLANT that is regulated by the FOOD regulatory agency that has jurisdiction over the plant.

3-201.13 Fluid Milk and Milk Products.* Fluid milk and milk products shall be obtained from sources that

comply with GRADE A STANDARDS as specified in LAW. 3-201.14 Fish.* (A) FISH that are received for sale or service shall be:

(1) Commercially and legally caught or harvested; or (2) APPROVED for sale or service.

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(B) MOLLUSCAN SHELLFISH that are recreationally caught may not be received for sale or service.

3-201.15 Molluscan Shellfish.* (A) MOLLUSCAN SHELLFISH shall be obtained from sources

according to LAW and the requirements specified in the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.

(B) MOLLUSCAN SHELLFISH received in interstate commerce shall

be from sources that are listed in the Interstate Certified Shellfish Shippers List.

3-201.16 Wild Mushrooms.* (A) Except as specified in ¶ (B) of this section, mushroom

species picked in the wild shall be obtained from sources where each mushroom is individually inspected and found to be safe by an APPROVED mushroom identification expert.

(B) This section does not apply to: (1) Cultivated wild mushroom species that are grown,

harvested, and processed in an operation that is regulated by the FOOD regulatory agency that has jurisdiction over the operation; or

(2) Wild mushroom species if they are in packaged form

and are the product of a FOOD PROCESSING PLANT that is regulated by the FOOD regulatory agency that has jurisdiction over the plant.

3-201.17 Game Animals.* (A) If GAME ANIMALS are received for sale or service they shall

be: (1) Commercially raised for FOOD and:

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(a) Raised, slaughtered, and processed under a voluntary inspection program that is conducted by the agency that has animal health jurisdiction, or

(b) Under a routine inspection program conducted by a

regulatory agency other than the agency that has animal health jurisdiction, and

(c) Raised, slaughtered, and processed according to:

(i) LAWS governing MEAT and POULTRY as determined

by the agency that has animal health jurisdiction and the agency that conducts the inspection program, and

(ii) Requirements which are developed by the

agency that has animal health jurisdiction and the agency that conducts the inspection program with consideration of factors such as the need for antemortem and postmortem examination by an APPROVED veterinarian or veterinarian’s designee;

(2) Under a voluntary inspection program administered by

the USDA for game animals such as exotic animals (reindeer, elk, deer, antelope, water buffalo, or bison) that are "inspected and APPROVED" in accordance with 9 CFR 352 Exotic animals; voluntary inspection or rabbits that are "inspected and certified" in accordance with 9 CFR 354 voluntary inspection of rabbits and edible products thereof;

(3) As allowed by LAW, for wild GAME ANIMALS that are live-

caught: (a) Under a routine inspection program conducted by a

regulatory agency such as the agency that has animal health jurisdiction, and

(b) Slaughtered and processed according to:

(i) LAWS governing MEAT and POULTRY as determined

by the agency that has animal health jurisdiction and the agency that conducts the inspection program, and

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(ii) Requirements which are developed by the agency that has animal health jurisdiction and the agency that conducts the inspection program with consideration of factors such as the need for antemortem and postmortem examination by an APPROVED veterinarian or veterinarian’s designee; or

(4) As allowed by LAW, for field-dressed wild GAME ANIMALS

under a routine inspection program that ensures the animals:

(a) Receive a postmortem examination by an APPROVED

veterinarian or veterinarian's designee, or (b) Are field-dressed and transported according to

requirements specified by the agency that has animal health jurisdiction and the agency that conducts the inspection program, and

(c) Are processed according to LAWS governing MEAT

and POULTRY as determined by the agency that has animal health jurisdiction and the agency that conducts the inspection program.

(B) A GAME ANIMAL may not be received for sale or service if it is

a species of wildlife that is listed in 50 CFR 17 Endangered and threatened wildlife and plants.

Specifications for Receiving

3-202.11 Temperature.* (A) Except as specified in ¶ (B) of this section, refrigerated, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) shall be at a temperature of 5oC (41oF) or below when received.

(B) If a temperature other than 5°C (41°F) for a POTENTIALLY

HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) is specified in LAW governing its distribution, such as LAWS governing milk and MOLLUSCAN SHELLFISH, the FOOD may be received at the specified temperature.

(C) Raw EGGS shall be received in refrigerated equipment that

maintains an ambient air temperature of 7oC (45oF) or less.

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(D) POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) that is cooked to a temperature and for a time

specified under §§ 3-401.11 - 3-401.13 and received hot shall be at a temperature of 57oC (135oF) or above.

(E) A FOOD that is labeled frozen and shipped frozen by a FOOD

PROCESSING PLANT shall be received frozen. (F) Upon receipt, POTENTIALLY HAZARDOUS FOOD

(TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) shall be free of evidence of previous temperature abuse.

3-202.12 Additives.*

FOOD may not contain unAPPROVED FOOD ADDITIVES or ADDITIVES that exceed amounts specified in 21 CFR 170-180 relating to FOOD ADDITIVES, generally recognized as safe or prior sanctioned substances that exceed amounts specified in 21 CFR 181-186, substances that exceed amounts specified in 9 CFR Subpart C Section 424.21(b) Food ingredients and sources of radiation, or pesticide residues that exceed provisions specified in 40 CFR 180Tolerances for pesticides chemicals in food, and exceptions.

3-202.13 Eggs.*

EGGS shall be received clean and sound and may not exceed the restricted EGG tolerances for U.S. Consumer Grade B as specified in United States Standards, Grades, and Weight Classes for Shell Eggs, AMS 56.200 et seq., administered by the Agricultural Marketing Service of USDA.

3-202.14 Eggs and Milk Products, Pasteurized.*

(A) EGG PRODUCTS shall be obtained pasteurized.

(B) Fluid and dry milk and milk products shall: (1) Be obtained pasteurized; and (2) Comply with GRADE A STANDARDS as specified in LAW. (C) Frozen milk products, such as ice cream, shall be obtained

pasteurized as specified in 21 CFR 135 - Frozen desserts.

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(D) Cheese shall be obtained pasteurized unless alternative

procedures to pasteurization are specified in the CFR, such as 21 CFR 133 - Cheeses and related cheese products, for curing certain cheese varieties.

3-202.15 Package Integrity.*

FOOD packages shall be in good condition and protect the integrity of the contents so that the FOOD is not exposed to ADULTERATION or potential contaminants.

3-202.16 Ice.*

Ice for use as a FOOD or a cooling medium shall be made from DRINKING WATER.

3-202.17 Shucked Shellfish, Packaging and

Identification. (A) Raw SHUCKED SHELLFISH shall be obtained in nonreturnable packages which bear a legible label that identifies the:

(1) Name, address, and CERTIFICATION NUMBER of the shucker-packer or repacker of the MOLLUSCAN SHELLFISH; and

(2) The "sell by" date for packages with a capacity of less than

1.89 L (one-half gallon) or the date shucked for packages with a capacity of 1.89 L (one-half gallon) or more.

(B) A package of raw SHUCKED SHELLFISH that does not bear a

label or which bears a label which does not contain all the information as specified under ¶ (A) of this section shall be subject to a hold order, as allowed by LAW, or seizure and destruction in accordance with 21 CFR Subpart D - Specific Administrative Decisions Regarding Interstate Shipments, Section 1240.60(d) Molluscan shellfish.

3-202.18 Shellstock Identification.*

(A) SHELLSTOCK shall be obtained in containers bearing legible source identification tags or labels that are affixed by the

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harvester and each dealer that depurates, ships, or reships the SHELLSTOCK, as specified in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, and that list:

(1) Except as specified under ¶ (C) of this section, on the

harvester's tag or label, the following information in the following order:

(a) The harvester's identification number that is assigned

by the SHELLFISH CONTROL AUTHORITY, (b) The date of harvesting, (c) The most precise identification of the harvest location

or aquaculture site that is practicable based on the system of harvest area designations that is in use by the SHELLFISH CONTROL AUTHORITY and including the abbreviation of the name of the state or country in which the shellfish are harvested,

(d) The type and quantity of shellfish, and (e) The following statement in bold, capitalized type: "This

tag is required to be attached until container is empty or retagged and thereafter kept on file for 90 days;" and

(2) Except as specified in ¶ (D) of this section, on each

dealer's tag or label, the following information in the following order:

(a) The dealer's name and address, and the CERTIFICATION

NUMBER assigned by the SHELLFISH CONTROL AUTHORITY, (b) The original shipper's CERTIFICATION NUMBER including

the abbreviation of the name of the state or country in which the shellfish are harvested,

(c) The same information as specified for a harvester's tag

under Subparagraphs (A)(1)(b)-(d) of this section, and (d) The following statement in bold, capitalized type: "This

tag is required to be attached until container is empty and thereafter kept on file for 90 days.@

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(B) A container of SHELLSTOCK that does not bear a tag or label or that bears a tag or label that does not contain all the information as specified under ¶ (A) of this section shall be subject to a hold order, as allowed by LAW, or seizure and destruction in accordance with 21 CFR Subpart D - Specific Administrative Decisions Regarding Interstate Shipments, Section 1240.60(d).

(C) If a place is provided on the harvester's tag or label for a

dealer's name, address, and CERTIFICATION NUMBER, the dealer's information shall be listed first.

(D) If the harvester's tag or label is designed to accommodate

each dealer's identification as specified under Subparagraphs (A)(2)(a) and (b) of this section, individual dealer tags or labels need not be provided.

3-202.19 Shellstock, Condition.

When received by a FOOD ESTABLISHMENT, SHELLSTOCK shall be reasonably free of mud, dead shellfish, and shellfish with broken shells. Dead shellfish or SHELLSTOCK with badly broken shells shall be discarded.

3-202.110 Juice Treated. Pre-PACKAGED JUICE shall: (A) Be obtained from a processor with a HACCP system as

specified in 21 CFR Part 120 Hazard Analysis and Critical Control (HACCP) Systems; and

(B) Be obtained pasteurized or otherwise treated to attain a

5-log reduction of the most resistant microorganism of public health significance as specified in 21 CFR Part 120.24 Process Controls.

3-203.11 Molluscan Shellfish, Original Container.

(A) Except as specified in ¶¶ (B) - (D) of this section, MOLLUSCAN SHELLFISH may not be removed from the container in which they are received other than immediately before sale or preparation for service.

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Original Containers and Records

(B) For display purposes, SHELLSTOCK may be removed from the container in which they are received, displayed on drained ice, or held in a display container, and a quantity specified by a CONSUMER may be removed from the display or display container and provided to the CONSUMER if:

(1) The source of the SHELLSTOCK on display is identified as

specified under § 3-202.18 and recorded as specified under § 3-203.12; and

(2) The SHELLSTOCK are protected from contamination. (C) SHUCKED SHELLFISH may be removed from the container in

which they were received and held in a display container from which individual servings are dispensed upon a CONSUMER'S request if:

(1) The labeling information for the shellfish on display as

specified under § 3-202.17 is retained and correlated to the date when, or dates during which, the shellfish are sold or served; and

(2) The shellfish are protected from contamination. (D) SHUCKED SHELLFISH may be removed from the container in

which they were received and repacked in CONSUMER self service containers where allowed by LAW if:

(1) The labeling information for the shellfish is on each

CONSUMER self service container as specified under § 3-202.17 and ¶¶ 3-602.11(A) and (B)(1) - (5);

(2) The labeling information as specified under § 3-202.17 is

retained and correlated with the date when, or dates during which, the shellfish are sold or served;

(3) The labeling information and dates specified under

Subparagraph (D)(2) of this section are maintained for 90 days; and

(4) The shellfish are protected from contamination.

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3-203.12 Shellstock, Maintaining Identification.* (A) Except as specified under Subparagraph (B)(2) of this section, SHELLSTOCK tags shall remain attached to the container in which the SHELLSTOCK are received until the container is empty.

(B) The identity of the source of SHELLSTOCK that are sold or

served shall be maintained by retaining SHELLSTOCK tags or labels for 90 calendar days from the dates of harvest:

(1) Using an APPROVED record keeping system that keeps the

tags or labels in chronological order correlated to the date when, or dates during which, the SHELLSTOCK are sold or served; and

(2) If SHELLSTOCK are removed from their tagged or labeled

container: (a) Preserving source identification by using a record

keeping system as specified under Subparagraph (B)(1) of this section, and

(b) Ensuring that SHELLSTOCK from one tagged or labeled

container are not COMMINGLED with SHELLSTOCK from another container with different CERTIFICATION NUMBERS; different harvest dates; or different growing areas as identified on the tag or label before being ordered by the CONSUMER.

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3-3 PROTECTION FROM CONTAMINATION AFTER RECEIVING Subparts 3-301 Preventing Contamination by Employees 3-302 Preventing Food and Ingredient Contamination 3-303 Preventing Contamination from Ice Used as a

Coolant 3-304 Preventing Contamination from Equipment, Utensils, and Linens 3-305 Preventing Contamination from the Premises 3-306 Preventing Contamination by Consumers 3-307 Preventing Contamination from Other Sources

Preventing Contamination by Employees

3-301.11 Preventing Contamination from Hands.* (A) FOOD EMPLOYEES shall wash their hands as specified under § 2-301.12.

(B) Except when washing fruits and vegetables as specified

under § 3-302.15 or as specified in ¶ (D) of this section, FOOD EMPLOYEES may not contact exposed, READY-TO-EAT FOOD with their bare hands and shall use suitable UTENSILS such as deli tissue, spatulas, tongs, single-use gloves, or dispensing EQUIPMENT.

(C) FOOD EMPLOYEES shall minimize bare hand and arm contact

with exposed FOOD that is not in a READY-TO-EAT form.S (D) FOOD EMPLOYEES not serving a HIGHLY SUSCEPTIBLE

POPULATION may contact exposed, READY-TO-EAT FOOD with their bare hands if:

(1) The PERMIT HOLDER obtains prior APPROVAL from the

REGULATORY AUTHORITY; (2) Written procedures are maintained in the FOOD

ESTABLISHMENT and made available to the REGULATORY AUTHORITY upon request that include:

(a) For each bare hand contact procedure, a listing of the

specific READY-TO-EAT FOODS that are touched by bare hands,

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(b) Diagrams and other information showing that handwashing facilities, installed, located, equipped, and maintained as specified under §§ 5-203.11, 5-204.11, 5-205.11, 6-301.11, 6-301.12, and 6-301.14, are in an easily accessible location and in close proximity to the work station where the bare hand contact procedure is conducted;

(3) A written EMPLOYEE health policy that details how the FOOD

ESTABLISHMENT complies with §§ 2-201.11, 2-201.12, and 2-201.13 including:

(a) Documentation that FOOD EMPLOYEES and CONDITIONAL

EMPLOYEES acknowledge that they are informed to report information about their health and activities as they relate to gastrointestinal symptoms and diseases that are transmittable through FOOD as specified under ¶ 2-201.11(A),

(b) Documentation that FOOD EMPLOYEES and CONDITIONAL

EMPLOYEES acknowledge their responsibilities as specified under ¶ 2-201.11(E) and (F), and

(c) Documentation that the PERSON IN CHARGE

acknowledges the responsibilities as specified under ¶¶ 2-201.11(B), (C) and (D), and §§ 2-201.12 and 2-201.13;

(4) Documentation that FOOD EMPLOYEES acknowledge that

they have received training in: (a) The RISKS of contacting the specific READY-TO-EAT

FOODS with bare hands, (b) Proper handwashing as specified under § 2-301.12, (c) When to wash their hands as specified under

§ 2-301.14, (d) Where to wash their hands as specified under

§ 2-301.15, (e) Proper fingernail maintenance as specified under

§ 2-302.11,

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(f) Prohibition of jewelry as specified under § 2-303.11, and

(g) Good hygienic practices as specified under §§2-401.11

and 2-401.12; (5) Documentation that hands are washed before FOOD

preparation and as necessary to prevent cross contamination by FOOD EMPLOYEES as specified under §§ 2-301.11, 2-301.12, 2-301.14, and 2-301.15 during all hours of operation when the specific READY-TO-EAT FOODS are prepared;

(6) Documentation that FOOD EMPLOYEES contacting READY-TO-

EAT FOOD with bare hands use two or more of the following control measures to provide additional safeguards to HAZARDSassociated with bare hand contact:

(a) Double handwashing, (b) Nail brushes, (c) A hand antiseptic after handwashing as specified

under § 2-301.16, (d) Incentive programs such as paid sick leave that assist

or encourage FOOD EMPLOYEES not to work when they are ill, or

(e) Other control measures APPROVED by the REGULATORY

AUTHORITY; and (7) Documentation that corrective action is taken when

Subparagraphs (D)(1) - (6) of this section are not followed. 3-301.12 Preventing Contamination When Tasting.*

A FOOD EMPLOYEE may not use a UTENSIL more than once to taste FOOD that is to be sold or served.

Preventing Food and Ingredient Contamination

3-302.11 Packaged and Unpackaged Food - Separation, Packaging, and Segregation.*

(A) FOOD shall be protected from cross contamination by:

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(1) Separating raw animal FOODS during storage, preparation,

holding, and display from: (a) Raw READY-TO-EAT FOOD including other raw animal

FOOD such as FISH for sushi or MOLLUSCAN SHELLFISH, or other raw READY-TO-EAT FOOD such as fruits and vegetables, and

(b) Cooked READY-TO-EAT FOOD; (2) Except when combined as ingredients, separating types of

raw animal FOODS from each other such as beef, FISH, lamb, pork, and POULTRY during storage, preparation, holding, and display by:

(a) Using separate EQUIPMENT for each type, or (b) Arranging each type of FOOD in EQUIPMENT so that

cross contamination of one type with another is prevented, and

(c) Preparing each type of FOOD at different times or in

separate areas; (3) Cleaning EQUIPMENT and UTENSILS as specified under

¶ 4-602.11(A) and SANITIZING as specified under § 4-703.11; (4) Except as specified under Subparagraph 3-501.15(B)(2)

and in ¶ (B) of this section, storing the FOOD in packages, covered containers, or wrappings;

(5) Cleaning HERMETICALLY SEALED CONTAINERS of FOOD of

visible soil before opening; (6) Protecting FOOD containers that are received packaged

together in a case or overwrap from cuts when the case or overwrap is opened;

(7) Storing damaged, spoiled, or recalled FOOD being held in

the FOOD ESTABLISHMENT as specified under § 6-404.11; and (8) Separating fruits and vegetables, before they are washed

as specified under § 3-302.15 from READY-TO-EAT FOOD.

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(B) Subparagraph (A)(4) of this section does not apply to: (1) Whole, uncut, raw fruits and vegetables and nuts in the

shell, that require peeling or hulling before consumption; (2) PRIMAL CUTS, quarters, or sides of raw MEAT or slab bacon

that are hung on clean, SANITIZED hooks or placed on clean, SANITIZED racks;

(3) Whole, uncut, processed MEATS such as country hams,

and smoked or cured sausages that are placed on clean, SANITIZED racks;

(4) FOOD being cooled as specified under Subparagraph

3-501.15(B)(2); or (5) SHELLSTOCK. 3-302.12 Food Storage Containers, Identified with

Common Name of Food. Except for containers holding FOOD that can be readily and unmistakably recognized such as dry pasta, working containers holding FOOD or FOOD ingredients that are removed from their original packages for use in the FOOD ESTABLISHMENT, such as cooking oils, flour, herbs, potato flakes, salt, spices, and sugar shall be identified with the common name of the FOOD.

3-302.13 Pasteurized Eggs, Substitute for Raw Eggs for

Certain Recipes.* Pasteurized EGGS or EGG PRODUCTS shall be substituted for raw EGGS in the preparation of FOODS such as Caesar salad, hollandaise or Béarnaise sauce, mayonnaise, meringue, eggnog, ice cream, and EGG-fortified BEVERAGES that are not:

(A) Cooked as specified under Subparagraphs 3-401.11(A)(1)

or (2); or (B) Included in ¶ 3-401.11(D).

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3-302.14 Protection from Unapproved Additives.* (A) FOOD shall be protected from contamination that may result from the addition of, as specified in § 3-202.12:

(1) Unsafe or unAPPROVED FOOD or COLOR ADDITIVES; and (2) Unsafe or unAPPROVED levels of APPROVED FOOD and

COLOR ADDITIVES. (B) A FOOD EMPLOYEE may not: (1) Apply sulfiting agents to fresh fruits and vegetables

intended for raw consumption or to a FOOD considered to be agood source of vitamin B1; or

(2) Except for grapes, serve or sell FOOD specified under

Subparagraph (B)(1) of this section that is treated with sulfiting agents before receipt by the FOOD ESTABLISHMENT.

3-302.15 Washing Fruits and Vegetables.

(A) Except as specified in ¶ (B) of this section and except for whole, raw fruits and vegetables that are intended for washing by the CONSUMER before consumption, raw fruits and vegetables shall be thoroughly washed in water to remove soil and other contaminants before being cut, combined with other ingredients, cooked, served, or offered for human consumption in READY-TO-EAT form.

(B) Fruits and vegetables may be washed by using chemicals as

specified under § 7-204.12. Preventing Contamination from Ice Used as a Coolant

3-303.11 Ice Used as Exterior Coolant, Prohibited as Ingredient.

After use as a medium for cooling the exterior surfaces of FOOD such as melons or FISH, PACKAGED FOODS such as canned BEVERAGES, or cooling coils and tubes of EQUIPMENT, ice may not be used as FOOD.

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3-303.12 Storage or Display of Food in Contact with Water or Ice.

(A) PACKAGED FOOD may not be stored in direct contact with ice or water if the FOOD is subject to the entry of water because of the nature of its packaging, wrapping, or container or its positioning in the ice or water.

(B) Except as specified in ¶¶ (C) and (D) of this section,

unPACKAGED FOOD may not be stored in direct contact with undrained ice.

(C) Whole, raw fruits or vegetables; cut, raw vegetables such as

celery or carrot sticks or cut potatoes; and tofu may be immersed in ice or water.

(D) Raw poultry and raw FISH that are received immersed in ice in

shipping containers may remain in that condition while in storage awaiting preparation, display, service, or sale.

Preventing Contamination from Equipment, Utensils, and Linens

3-304.11 Food Contact with Equipment and Utensils.* FOOD shall only contact surfaces of: (A) EQUIPMENT and UTENSILS that are cleaned as specified

under Part 4-6 of this Code and SANITIZED as specified under Part 4-7 of this Code; or

(B) SINGLE-SERVICE and SINGLE-USE ARTICLES. 3-304.12 In-Use Utensils, Between-Use Storage.

During pauses in FOOD preparation or dispensing, FOOD preparation and dispensing UTENSILS shall be stored:

(A) Except as specified under ¶ (B) of this section, in the

FOOD with their handles above the top of the FOOD and the container;

(B) In FOOD that is not POTENTIALLY HAZARDOUS

(TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) with their handles above the top of the FOOD within containers or

EQUIPMENT that can be closed, such as bins of sugar, flour, or cinnamon;

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(C) On a clean portion of the FOOD preparation table or

cooking EQUIPMENT only if the in-use UTENSIL and the FOOD-CONTACT surface of the FOOD preparation table or cooking EQUIPMENT are cleaned and SANITIZED at a frequency specified under §§ 4-602.11 and 4-702.11;

(D) In running water of sufficient velocity to flush particulates

to the drain, if used with moist FOOD such as ice cream or mashed potatoes;

(E) In a clean, protected location if the UTENSILS, such as ice

scoops, are used only with a FOOD that is not POTENTIALLY HAZARDOUS (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD); or

(F) In a container of water if the water is maintained at a

temperature of at least 57oC (135oF) and the container is cleaned at a frequency specified under Subparagraph

4-602.11(D)(7). 3-304.13 Linens and Napkins, Use Limitation.

LINENS and napkins may not be used in contact with FOOD unless they are used to line a container for the service of FOODS and the LINENS and napkins are replaced each time the container is refilled for a new CONSUMER.

3-304.14 Wiping Cloths, Use Limitation.

(A) Cloths in-use for wiping FOOD spills from TABLEWARE and carry-out containers that occur as FOOD is being served shall be:

(1) Maintained dry; and (2) Used for no other purpose. (B) Cloths in-use for wiping counters and other EQUIPMENT

surfaces shall be: (1) Held between uses in a chemical sanitizer solution at a

concentration specified under § 4-501.114; and (2) Laundered daily as specified under ¶ 4-802.11(D).

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(C) Cloths in-use for wiping surfaces in contact with raw animal FOODS shall be kept separate from cloths used for other purposes.

(D) Dry wiping cloths and the chemical sanitizing solutions

specified in Subparagraph (B)(1) of this section in which wet wiping cloths are held between uses shall be free of FOOD debris and visible soil.

(E) Containers of chemical sanitizing solutions specified in

Subparagraph (B)(1) of this section in which wet wiping cloths are held between uses shall be stored off the floor and used in a manner that prevents contamination of FOOD, EQUIPMENT, UTENSILS, LINENS, SINGLE-SERVICE, or SINGLE-USE ARTICLES.

(F) SINGLE-USE disposable sanitizer wipes shall be used in

accordance with EPA-approved manufacturer’s label use instructions.

3-304.15 Gloves, Use Limitation.

(A) If used, SINGLE-USE gloves shall be used for only one task such as working with READY-TO-EAT FOOD or with raw animal FOOD, used for no other purpose, and discarded when damaged or soiled, or when interruptions occur in the operation.

(B) Except as specified in ¶ (C) of this section, slash-resistant

gloves that are used to protect the hands during operations requiring cutting shall be used in direct contact only with FOOD that is subsequently cooked as specified under Part 3-4 such as frozen FOOD or a PRIMAL CUT of MEAT.

(C) Slash-resistant gloves may be used with READY-TO-EAT FOOD

that will not be subsequently cooked if the slash-resistant gloves have a SMOOTH, durable, and nonabsorbent outer surface; or if the slash-resistant gloves are covered with a SMOOTH, durable, nonabsorbent glove, or a SINGLE-USE glove.

(D) Cloth gloves may not be used in direct contact with FOOD

unless the FOOD is subsequently cooked as required under Part 3-4 such as frozen FOOD or a PRIMAL CUT of MEAT.

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3-304.16 Using Clean Tableware for Second Portions and Refills.

(A) Except for refilling a CONSUMER=S drinking cup or container without contact between the pouring UTENSIL and the lip-contact area of the drinking cup or container, FOOD EMPLOYEES may not use TABLEWARE, including SINGLE-SERVICE ARTICLES, soiled by the CONSUMER, to provide second portions or refills.

(B) Except as specified in ¶ (C) of this section, self-service

CONSUMERS may not be allowed to use soiled TABLEWARE, including SINGLE-SERVICE ARTICLES, to obtain additional FOOD from the display and serving EQUIPMENT.

(C) Drinking cups and containers may be reused by self-service

CONSUMERS if refilling is a contamination-free process as specified under ¶¶ 4-204.13(A), (B), and (D).

3-304.17 Refilling Returnables.

(A) A take-home FOOD container returned to a FOOD ESTABLISHMENT may not be refilled at a FOOD ESTABLISHMENT with a POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD).

(B) Except as specified in ¶ (C), a take-home FOOD container

refilled with FOOD that is not POTENTIALLY HAZARDOUS (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) shall be cleaned as specified under ¶ 4-603.17(B).

(C) Personal take-out BEVERAGE containers, such as thermally

insulated bottles, nonspill coffee cups, and promotional BEVERAGEglasses, may be refilled by EMPLOYEES or the CONSUMER if refilling is a contamination-free process as specified under ¶¶ 4-204.13(A), (B), and (D).

Preventing Contamination from the Premises

3-305.11 Food Storage. (A) Except as specified in ¶¶ (B) and (C) of this section, FOOD shall be protected from contamination by storing the FOOD:

(1) In a clean, dry location;

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(2) Where it is not exposed to splash, dust, or other contamination; and

(3) At least 15 cm (6 inches) above the floor. (B) FOOD in packages and working containers may be stored less

than 15 cm (6 inches) above the floor on case lot handling EQUIPMENT as specified under § 4-204.122.

(C) Pressurized BEVERAGE containers, cased FOOD in waterproof

containers such as bottles or cans, and milk containers in plasticcrates may be stored on a floor that is clean and not exposed to floor moisture.

3-305.12 Food Storage, Prohibited Areas.

FOOD may not be stored:

(A) In locker rooms;

(B) In toilet rooms;

(C) In dressing rooms;

(D) In garbage rooms;

(E) In mechanical rooms; (F) Under sewer lines that are not shielded to intercept

potential drips; (G) Under leaking water lines, including leaking automatic fire

sprinkler heads, or under lines on which water has condensed;

(H) Under open stairwells; or

(I) Under other sources of contamination.

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3-305.13 Vended Potentially Hazardous Food (Time/Temperature Control for Safety Food), Original Container.

POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) dispensed through a VENDING MACHINE shall be in the PACKAGE in which it was placed at the FOOD ESTABLISHMENT or FOOD PROCESSING PLANT at which it was prepared.

3-305.14 Food Preparation.

During preparation, unPACKAGED FOOD shall be protected from environmental sources of contamination.

Preventing Contamination by Consumers

3-306.11 Food Display. Except for nuts in the shell and whole, raw fruits and vegetables that are intended for hulling, peeling, or washing by the CONSUMER before consumption, FOOD on display shall be protected from contamination by the use of PACKAGING; counter, service line, or salad bar FOOD guards; display cases; or other effective means.

3-306.12 Condiments, Protection.

(A) Condiments shall be protected from contamination by being kept in dispensers that are designed to provide protection, protected FOOD displays provided with the proper UTENSILS, original containers designed for dispensing, or individual PACKAGES or portions.

(B) Condiments at a VENDING MACHINE LOCATION shall be in

individual PACKAGES or provided in dispensers that are filled at an APPROVED location, such as the FOOD ESTABLISHMENT that provides FOOD to the VENDING MACHINE LOCATION, a FOOD PROCESSING PLANT that is regulated by the agency that has jurisdiction over the operation, or a properly equipped facility that is located on the site of the VENDING MACHINE LOCATION.

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3-306.13 Consumer Self-Service Operations.* (A) Raw, unPACKAGED animal FOOD, such as beef, lamb, pork, POULTRY, and FISH may not be offered for CONSUMER self-service. This paragraph does not apply to:

(1) CONSUMER self-service of READY-TO-EAT FOODS at buffets

or salad bars that serve FOODS such as sushi or raw shellfish; (2) Ready-to-cook individual portions for immediate cooking

and consumption on the PREMISES such as CONSUMER-cooked MEATS or CONSUMER-selected ingredients for Mongolian barbecue; or

(3) Raw, frozen, shell-on shrimp, or lobster. (B) CONSUMER self-service operations for READY-TO-EAT FOODS

shall be provided with suitable UTENSILS or effective dispensing methods that protect the FOOD from contamination.N

(C) CONSUMER self-service operations such as buffets and salad

bars shall be monitored by FOOD EMPLOYEES trained in safe operating procedures.N

3-306.14 Returned Food and Re-Service of Food.*

(A) Except as specified in ¶ (B) of this section, after being served or sold and in the possession of a CONSUMER, FOOD that is unused or returned by the CONSUMER may not be offered as FOODfor human consumption.

(B) Except as specified under ¶ 3-801.11(G), a container of FOOD

that is not POTENTIALLY HAZARDOUS (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) may be RE-SERVED from one CONSUMER to another if:

(1) The FOOD is dispensed so that it is protected from

contamination and the container is closed between uses, such as a narrow-neck bottle containing catsup, steak sauce, or wine; or

(2) The FOOD, such as crackers, salt, or pepper, is in an

unopened original PACKAGE and is maintained in sound condition.

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Preventing Contamination from Other Sources

3-307.11 Miscellaneous Sources of Contamination. FOOD shall be protected from contamination that may result from a factor or source not specified under Subparts 3-301 - 3-306.

3-4 DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN

Subparts 3-401 Cooking 3-402 Freezing 3-403 Reheating 3-404 Other Methods

Cooking 3-401.11 Raw Animal Foods.*

(A) Except as specified under ¶ (B) and in ¶¶ (C) and (D) of this section, raw animal FOODS such as EGGS, FISH, MEAT, POULTRY, and FOODS containing these raw animal FOODS, shall be cooked to heat all parts of the FOOD to a temperature and for a time that complies with one of the following methods based on the FOOD that is being cooked:

(1) 63oC (145oF) or above for 15 seconds for: (a) Raw EGGS that are broken and prepared in response to

a CONSUMER'S order and for immediate service, and (b) Except as specified under Subparagraphs (A)(2) and

(A)(3) and ¶ (B), and in ¶ (C) of this section, FISH and MEATincluding GAME ANIMALS commercially raised for FOOD as specified under Subparagraph 3-201.17(A)(1) and GAME ANIMALS under a voluntary inspection program as specified under Subparagraph 3-201.17(A)(2);

(2) 68oC (155oF) for 15 seconds or the temperature specified

in the following chart that corresponds to the holding time for RATITES and INJECTED MEATS; the following if they are COMMINUTED: FISH, MEAT, GAME ANIMALS commercially raised for FOOD as specified under Subparagraph 3-201.17(A)(1), and GAME ANIMALS under a voluntary inspection program as specified under Subparagraph 3-201.17(A)(2); and raw EGGS

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that are not prepared as specified under Subparagraph (A)(1)(a) of this section:

Minimum Temperature Time oC (oF)

63 (145) 3 minutes 66 (150) 1 minute 70 (158) < 1 second (instantaneous)

;or (3) 74oC (165oF) or above for 15 seconds for POULTRY,

BALUTS, wild GAME ANIMALS as specified under Subparagraphs 3-201.17(A)(3) and (4), stuffed FISH, stuffed MEAT, stuffed pasta, stuffed POULTRY, stuffed RATITES, or stuffing containing FISH, MEAT, POULTRY, or RATITES.

(B) Whole MEAT roasts including beef, corned beef, lamb, pork,

and cured pork roasts such as ham shall be cooked: (1) In an oven that is preheated to the temperature specified

for the roast's weight in the following chart and that is held at that temperature:

Oven Temperature Based on Roast Weight

Oven Type

Less than 4.5 kg (10 lbs)

4.5 kg (10 lbs) or More

Still Dry

177oC (350oF) or more

121oC (250oF) or more

Convection

163oC (325oF) or more

121oC (250oF) or more

High Humidity1

121oC (250oF) or less

121oC (250oF) or less

1 Relative humidity greater than 90% for at least 1 hour as measured in the cooking chamber or exit of the oven; or in a moisture-impermeable bag that provides 100% humidity.

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; and (2) As specified in the following chart, to heat all parts of the

FOOD to a temperature and for the holding time that corresponds to that temperature:

Temperature °C (°F)

Time1 in Minutes

Temperature °C (°F)

Time1 in Seconds

54.4 (130) 112 63.9 (147) 134 55.0 (131) 89 65.0 (149) 85 56.1 (133) 56 66.1 (151) 54 57.2 (135) 36 67.2 (153) 34 57.8 (136) 28 68.3 (155) 22 58.9 (138) 18 69.4 (157) 14 60.0 (140) 12 70.0 (158) 0 61.1 (142) 8 62.2 (144) 5 62.8 (145) 4 1Holding time may include postoven heat rise.

(C) A raw or undercooked WHOLE-MUSCLE, INTACT BEEF steak may be served or offered for sale in a READY-TO-EAT form if:

(1) The FOOD ESTABLISHMENT serves a population that is not a

HIGHLY SUSCEPTIBLE POPULATION, (2) The steak is labeled to indicate that it meets the definition

of "WHOLE-MUSCLE, INTACT BEEF" as specified under ¶ 3-201.11(E), and

(3) The steak is cooked on both the top and bottom to a

surface temperature of 63oC (145oF) or above and a cooked color change is achieved on all external surfaces.

(D) A raw animal FOOD such as raw EGG, raw FISH, raw-marinated

FISH, raw MOLLUSCAN SHELLFISH, or steak tartare; or a partially cooked FOOD such as lightly cooked FISH, soft cooked EGGS, or rare MEAT other than WHOLE-MUSCLE, INTACT BEEF steaks as specified in ¶ (C) of this section, may be served or offered for sale upon CONSUMER request or selection in a READY-TO-EAT form if:

(1) As specified under ¶¶ 3-801.11(C)(1) and (2), the FOOD

ESTABLISHMENT serves a population that is not a HIGHLY SUSCEPTIBLE POPULATION; and

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(2) The CONSUMER is informed as specified under § 3-603.11

that to ensure its safety, the FOOD should be cooked as specified under ¶ (A) or (B) of this section; or

(3) The REGULATORY AUTHORITY grants a VARIANCE from ¶ (A) or (B) of this section as specified in ' 8-103.10 based on a HACCP PLAN that:

(a) Is submitted by the PERMIT HOLDER and APPROVED

as specified under § 8-103.11, (b) Documents scientific data or other information

showing that a lesser time and temperature regimen results in a safe FOOD, and

(c) Verifies that EQUIPMENT and procedures for FOOD

preparation and training of FOOD EMPLOYEES at the FOOD ESTABLISHMENT meet the conditions of the VARIANCE.

3-401.12 Microwave Cooking.*

Raw animal FOODS cooked in a microwave oven shall be:

(A) Rotated or stirred throughout or midway during cooking to

compensate for uneven distribution of heat; (B) Covered to retain surface moisture; (C) Heated to a temperature of at least 74oC (165oF) in all

parts of the FOOD; and (D) Allowed to stand covered for 2 minutes after cooking to

obtain temperature equilibrium. 3-401.13 Plant Food Cooking for Hot Holding.

Fruits and vegetables that are cooked for hot holding shall be cooked to a temperature of 57oC (135oF).

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Freezing 3-402.11 Parasite Destruction.* (A) Except as specified in ¶ (B) of this section, before service or sale in READY-TO-EAT form, raw, raw-marinated, partially cooked, or marinated-partially cooked FISH shall be:

(1) Frozen and stored at a temperature of -20°C (-4°F) or

below for a minimum of 168 hours (7 days) in a freezer; (2) Frozen at -35°C (-31°F) or below until solid and stored at

-35°C (-31°F) or below for a minimum of 15 hours; or (3) Frozen at -35°C (-31°F) or below until solid and stored at

-20°C (-4°F) or below for a minimum of 24 hours. (B) Paragraph (A) of this section does not apply to: (1) MOLLUSCAN SHELLFISH; (2) Tuna of the species Thunnus alalunga, Thunnus

albacares (Yellowfin tuna), Thunnus atlanticus, Thunnus maccoyii (Bluefin tuna, Southern), Thunnus obesus (Bigeye tuna), or Thunnus thynnus (Bluefin tuna, Northern); or

(3) Aquacultured FISH, such as salmon, that: (a) If raised in open water, are raised in net-pens, or (b) Are raised in land-based operations such as ponds or

tanks, and (c) Are fed formulated feed, such as pellets, that contains

no live parasites infective to the aquacultured FISH. 3-402.12 Records, Creation and Retention. (A) Except as specified in ¶ 3-402.11(B) and ¶ (B) of this section,

if raw, raw-marinated, partially cooked, or marinated-partially cooked FISH are served or sold in READY-TO-EAT form, the PERSON IN CHARGE shall record the freezing temperature and time to which the FISH are subjected and shall retain the records of the FOOD ESTABLISHMENT for 90 calendar days beyond the time of service or sale of the FISH.

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(B) If the FISH are frozen by a supplier, a written agreement or statement from the supplier stipulating that the FISH supplied are frozen to a temperature and for a time specified under § 3-402.11 may substitute for the records specified under ¶ (A) of this section.

(C) If raw, raw-marinated, partially cooked, or marinated-partially

cooked FISH are served or sold in READY-TO-EAT form, and the FISH are raised and fed as specified in Subparagraph 3-402.11(B)(3), a written agreement or statement from the supplier or aquaculturist stipulating that the FISH were raised and fed as specified in Subparagraph 3-402.11(B)(3) shall be obtained by the PERSON IN CHARGE and retained in the records of the FOOD ESTABLISHMENT for 90 calendar days beyond the time of service or sale of the FISH.

3-403.10 Preparation for Immediate Service.

Cooked and refrigerated FOOD that is prepared for immediate service in response to an individual CONSUMER order, such as a roast beef sandwich au jus, may be served at any temperature.

Reheating 3-403.11 Reheating for Hot Holding.*

(A) Except as specified under ¶¶ (B) and (C) and in ¶ (E) of this section, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) that is cooked, cooled, and reheated for hot holding shall be reheated so that all parts of the FOOD reach a temperature of at least 74oC (165oF) for 15 seconds.

(B) Except as specified under ¶ (C) of this section, POTENTIALLY

HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) reheated in a microwave oven for hot holding shall be reheated so that all parts of the FOOD reach a temperature of at least 74oC (165oF) and the FOOD is rotated or stirred, covered, and allowed to stand covered for 2 minutes after reheating.

(C) READY-TO-EAT FOOD taken from a commercially processed,

HERMETICALLY SEALED CONTAINER, or from an intact package from a FOOD PROCESSING PLANT that is inspected by the FOOD REGULATORY AUTHORITY that has jurisdiction over the plant, shall be heated to a temperature of at least 57oC (135oF) for hot holding.

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(D) Reheating for hot holding as specified under ¶¶ (A) - (C) of this section shall be done rapidly and the time the FOOD is between the temperature specified under Subparagraph 3-501.16(A)(2) and the temperatures specified under ¶¶ (A) - (C) of this section may not exceed 2 hours.

(E) Remaining unsliced portions of MEAT roasts that are cooked

as specified under ¶ 3-401.11(B) may be reheated for hot holding using the oven parameters and minimum time and temperature conditions specified under ¶ 3-401.11(B).

Other Methods 3-404.11 Treating Juice.

JUICE PACKAGED in a FOOD ESTABLISHMENT shall be:

(A) Treated under a HACCP PLAN as specified in

¶¶ 8-201.12(B) - (E) to attain a 5-log reduction, which is equal to a 99.999% reduction, of the most resistant microorganism of public health significance; or

(B) Labeled, if not treated to yield a 5-log reduction of the

most resistant microorganism of public health significance: (1) As specified under § 3-602.11, and (2) As specified in 21 CFR 101.17(g) Food labeling,

warning, notice, and safe handling statements, Juices that have not been specifically processed to prevent, reduce, or eliminate the presence of pathogens with the following, "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems."

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3-5 LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH CONCERN

Subparts

3-501 Temperature and Time Control 3-502 Specialized Processing Methods

Temperature and Time Control

3-501.11 Frozen Food. Stored frozen FOODS shall be maintained frozen.

3-501.12 Potentially Hazardous Food (Time/Temperature

Control for Safety Food), Slacking. Frozen POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) that is slacked to moderate the temperature shall be held:

(A) Under refrigeration that maintains the FOOD temperature at

5oC (41oF) or less, or at 7oC (45oF) or less as specified under Subparagraph 3-501.16(A)(2); or

(B) At any temperature if the FOOD remains frozen. 3-501.13 Thawing.

Except as specified in ¶ (D) of this section, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) shall be thawed:

(A) Under refrigeration that maintains the FOOD temperature at

5oC (41oF) or less, or at 7oC (45oF) or less as specified under Subparagraph 3-501.16(A)(2); or

(B) Completely submerged under running water:

(1) At a water temperature of 21oC (70oF) or below,

(2) With sufficient water velocity to agitate and float off

loose particles in an overflow, and

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(3) For a period of time that does not allow thawed portions

of READY-TO-EAT FOOD to rise above 5oC (41oF), or 7oC (45oF) as specified under Subparagraph 3-501.16(A)(2), or

(4) For a period of time that does not allow thawed portions

of a raw animal FOOD requiring cooking as specified under ¶ 3-401.11(A) or (B) to be above 5oC (41oF), or 7oC (45oF) as specified under Subparagraph 3-501.16(A)(2), for more than 4 hours including:

(a) The time the FOOD is exposed to the running water

and the time needed for preparation for cooking, or (b) The time it takes under refrigeration to lower the

FOOD temperature to 5oC (41oF), or 7oC (45oF) as specified under Subparagraph 3-501.16(A)(2);

(C) As part of a cooking process if the FOOD that is frozen is: (1) Cooked as specified under ¶ 3-401.11(A) or (B) or

§ 3-401.12, or (2) Thawed in a microwave oven and immediately

transferred to conventional cooking EQUIPMENT, with no interruption in the process; or

(D) Using any procedure if a portion of frozen READY-TO-EAT

FOOD is thawed and prepared for immediate service in response to an individual CONSUMER'S order.

3-501.14 Cooling.* (A) Cooked POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE

CONTROL FOR SAFETY FOOD) shall be cooled:

(1) Within 2 hours from 57ºC (135ºF) to 21ºC (70°F); and (2) Within a total of 6 hours from 57ºC (135ºF) to 5ºC (41°F) or

less, or to 7ºC (45°F) or less as specified under Subparagraph 3-501.16(A)(2)(b).

(B) POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL

FOR SAFETY FOOD) shall be cooled within 4 hours to 5oC (41oF) or

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less, or to 7oC (45oF) as specified under Subparagraph 3-501.16(A)(2)(b) if prepared from ingredients at ambient temperature, such as reconstituted FOODS and canned tuna.

(C) Except as specified under ¶ (D) of this section, a POTENTIALLY

HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) received in compliance with LAWS allowing a temperature above 5oC (41oF) during shipment from the supplier as specified in ¶ 3-202.11(B), shall be cooled within 4 hours to 5oC (41oF) or less, or 7oC (45oF) or less as specified under Subparagraph 3-501.16(A)(2)(b).

(D) Raw EGGS shall be received as specified under

¶ 3-202.11(C) and immediately placed in refrigerated EQUIPMENT that maintains an ambient air temperature of 7oC (45oF) or less.

3-501.15 Cooling Methods. (A) Cooling shall be accomplished in accordance with the time

and temperature criteria specified under ' 3-501.14 by using one or more of the following methods based on the type of FOOD being cooled:

(1) Placing the FOOD in shallow pans; (2) Separating the FOOD into smaller or thinner portions; (3) Using rapid cooling EQUIPMENT; (4) Stirring the FOOD in a container placed in an ice water bath; (5) Using containers that facilitate heat transfer; (6) Adding ice as an ingredient; or (7) Other effective methods. (B) When placed in cooling or cold holding EQUIPMENT, FOOD

containers in which FOOD is being cooled shall be: (1) Arranged in the EQUIPMENT to provide maximum heat

transfer through the container walls; and (2) Loosely covered, or uncovered if protected from overhead

contamination as specified under Subparagraph

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3-305.11(A)(2), during the cooling period to facilitate heat transfer from the surface of the FOOD.

3-501.16 Potentially Hazardous Food (Time/Temperature

Control for Safety Food), Hot and Cold Holding.* (A) Except during preparation, cooking, or cooling, or when time is

used as the public health control as specified under ' 3-501.19, and except as specified under ¶ (B) of this section, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) shall be maintained:

(1) At 57oC (135oF) or above, except that roasts cooked to a

temperature and for a time specified in ¶ 3-401.11(B) or reheated as specified in ¶ 3-403.11(E) may be held at a temperature of 54oC (130oF) or above; or

(2) At a temperature specified in the following: (a) 5oC (41oF) or less; or (b) 7°C (45°F) or between 5°C (41°F) and 7°C (45°F) in

existing refrigeration EQUIPMENT that is not capable of maintaining the FOOD at 5°C (41°F) or less if:

(i) The EQUIPMENT is in place and in use in the FOOD

ESTABLISHMENT, and (ii) Within 5 years of the REGULATORY AUTHORITY'S

adoption of this Code, the EQUIPMENT is upgraded or replaced to maintain FOOD at a temperature of 5°C (41°F) or less.

(B) EGGS that have not been treated to destroy all viable

Salmonellae shall be stored in refrigerated EQUIPMENT that maintains an ambient air temperature of 7°C (45°F) or less.

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on-premises preparation $ prepare and hold cold

3-501.17 Ready-to-Eat, Potentially Hazardous Food (Time/Temperature Control for Safety Food), Date Marking.* (A) Except when PACKAGING FOOD using a REDUCED OXYGEN PACKAGING method as specified under § 3-502.12, and except as specified in ¶¶ (D) and (E) of this section, refrigerated, READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) prepared and held in a FOOD ESTABLISHMENT for more than 24 hours shall be clearly marked to indicate the date or day by which the FOOD shall be consumed on the PREMISES, sold, or discarded, based on the temperature and time combinations specified below. The day of preparation shall be counted as Day 1.

(1) 5°C (41°F) or less for a maximum of 7 days; or (2) 7°C (45°F) or between 5°C (41°F) and 7°C (45°F) for a

maximum of 4 days in existing refrigeration EQUIPMENT that is not capable of maintaining the FOOD at 5°C (41°F) or less if:

(a) The EQUIPMENT is in place and in use in the FOOD

ESTABLISHMENT, and (b) Within 5 years of the REGULATORY AUTHORITY’S adoption

of this Code, the EQUIPMENT is upgraded or replaced to maintain FOOD at a temperature of 5°C (41°F) or less.

commercially processed food $ open and hold cold

(B) Except as specified in ¶¶ (D) - (F) of this section, refrigerated, READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) prepared and PACKAGED by a FOOD PROCESSING PLANT shall be clearly marked, at the time the original container is opened in a FOOD ESTABLISHMENT and if the FOOD is held for more than 24 hours, to indicate the date or day by which the FOOD shall be consumed on the PREMISES, sold, or discarded, based on the temperature and time combinations specified in ¶ (A) of this section and:

(1) The day the original container is opened in the FOOD

ESTABLISHMENT shall be counted as Day 1; and (2) The day or date marked by the FOOD ESTABLISHMENT may

not exceed a manufacturer’s use-by date if the manufacturer determined the use-by date based on FOOD safety.

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(C) A refrigerated, READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) ingredient or a portion of a refrigerated, READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) that is subsequently combined with additional ingredients or portions of FOOD shall retain the date marking of the earliest-prepared or first-prepared ingredient.

(D) A date marking system that meets the criteria stated in ¶¶ (A)

and (B) of this section may include: (1) Using a method APPROVED by the REGULATORY AUTHORITY

for refrigerated, READY-TO-EAT POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) that is frequently rewrapped, such as lunchmeat or a roast, or for which date marking is impractical, such as soft serve mix or milk in a dispensing machine;

(2) Marking the date or day of preparation, with a procedure

to discard the FOOD or on before the last date or day by which the FOOD must be consumed on the premises, sold, or discarded as specified under ¶ (A) of this section;

(3) Marking the date or day the original container is opened in

a FOOD ESTABLISHMENT, with a procedure to discard the FOOD on or before the last date or day by which the FOOD must be consumed on the premises, sold, or discarded as specified under ¶ (B) of this section; or

(4) Using calendar dates, days of the week, color-coded

marks, or other effective marking methods, provided that the marking system is disclosed to the REGULATORY AUTHORITY upon request.

(E) Paragraphs (A) and (B) of this section do not apply to

individual meal portions served or rePACKAGED for sale from a bulk container upon a consumer’s request.

(F) Paragraph (B) of this section does not apply to the following

FOODS prepared and PACKAGED by a FOOD PROCESSING PLANT inspected by a REGULATORY AUTHORITY:

(1) Deli salads, such as ham salad, seafood salad, chicken

salad, egg salad, pasta salad, potato salad, and macaroni salad, manufactured in accordance with 21 CFR 110 Current good manufacturing practice in manufacturing, packing, or holding human food;

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(2) Hard cheeses containing not more than 39% moisture as

defined in 21 CFR 133 Cheeses and related cheese products, such as cheddar, gruyere, parmesan and reggiano, and romano;

(3) Semi-soft cheeses containing more than 39% moisture, but

not more than 50% moisture, as defined in 21 CFR 133 Cheeses and related cheese products, such as blue, edam, gorgonzola, gouda, and monterey jack;

(4) Cultured dairy products as defined in 21 CFR 131 Milk and

cream, such as yogurt, sour cream, and buttermilk; (5) Preserved FISH products, such as pickled herring and dried

or salted cod, and other acidified FISH products defined in 21 CFR 114 Acidified foods;

(6) Shelf stable, dry fermented sausages, such as pepperoni

and Genoa salami that are not labeled "Keep Refrigerated" as specified in 9 CFR 317 Labeling, marking devices, and containers, and which retain the original CASING on the product; and

(7) Shelf stable salt-cured products such as prosciutto and

Parma (ham) that are not labeled "Keep Refrigerated" as specified in 9 CFR 317 Labeling, marking devices, and containers.

3-501.18 Ready-to-Eat, Potentially Hazardous Food

(Time/Temperature Control for Safety Food), Disposition.*

(A) A FOOD specified in ¶ 3-501.17(A) or (B) shall be discarded if it:

(1) Exceeds either of the temperature and time combinations

specified in ¶ 3-501.17(A), except time that the product is frozen;

(2) Is in a container or PACKAGE that does not bear a date or

day; or

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(3) Is appropriately marked with a date or day that exceeds a temperature and time combination as specified in

¶ 3-501.17(A). (B) Refrigerated, READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD

(TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) prepared in a FOOD ESTABLISHMENT and dispensed through a VENDING MACHINE with an automatic shutoff control shall be discarded if it exceeds a temperature and time combination as specified in ¶ 3-501.17(A).

3-501.19 Time as a Public Health Control.*

(A) Except as specified under ¶ (D) of this section, if time only is used as the public health control for a working supply of POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) before cooking, or for READY-TO-EAT POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) that is displayed or held for service for immediate consumption:

(1) Written procedures shall be prepared in advance,

maintained in the FOOD ESTABLISHMENT and made available to the REGULATORY AUTHORITY upon request that specify:

(a) Methods of compliance with Subparagraphs (B)(1)-(3)

or (C)(1)-(5) of this section; and (b) Methods of compliance with § 3-501.14 for FOOD that is

prepared, cooked, and refrigerated before time is used as a public health control.

Time – maximum up to 4 hours

(B) If time only, rather than time in conjunction with temperature control, up to a maximum of 4 hours, is used as the public health control:

(1) The FOOD shall have an initial temperature of 5ºC (41ºF) or

less if removed from cold holding temperature control, or 57°C (135°F) or greater if removed from hot holding temperature control;

(2) The FOOD shall be marked or otherwise identified to

indicate the time that is 4 hours past the point in time when the FOOD is removed from temperature control;

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(3) The FOOD shall be cooked and served, served if READY-TO-EAT, or discarded, within 4 hours from the point in time when the FOOD is removed from temperature control; and

(4) The FOOD in unmarked containers or PACKAGES, or marked

to exceed a 4-hour limit shall be discarded. Time – maximum up to 6 hours

(C) If time only, rather than time in conjunction with temperature control, up to a maximum of 6 hours, is used as the public health control:

(1) The FOOD shall have an initial temperature of 5ºC (41ºF) or

less when removed from temperature control and the FOOD temperature may not exceed 21ºC (70ºF) within a maximum time period of 6 hours;

(2) The FOOD shall be monitored to ensure the warmest

portion of the FOOD does not exceed 21ºC (70ºF) during the 6-hour period, unless an ambient air temperature is maintained that ensures the FOOD does not exceed 21ºC (70ºF) during the 6-hour holding period;

(3) The FOOD shall be marked or otherwise identified to

indicate: (a) The time when the FOOD is removed from 5ºC (41ºF) or

less cold holding temperature control, and (b) The time that is 6 hours past the point in time when the

FOOD is removed from cold holding temperature control; (4) The FOOD shall be: (a) Discarded if the temperature of the FOOD exceeds 21°C

(70°F), or (b) Cooked and served, served if READY-TO-EAT, or

discarded within a maximum of 6 hours from the point in time when the FOOD is removed from 5ºC (41ºF) or less cold holding temperature control; and

(5) The FOOD in unmarked containers or PACKAGES, or marked

with a time that exceeds the 6-hour limit shall be discarded. (D) A FOOD ESTABLISHMENT that serves a HIGHLY SUSCEPTIBLE

POPULATION may not use time as specified under ¶¶ (A), (B) or (C)

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of this section as the public health control for raw EGGS. Specialized Processing Methods

3-502.11 Variance Requirement.* A FOOD ESTABLISHMENT shall obtain a VARIANCE from the REGULATORY AUTHORITY as specified in ' 8-103.10 and under ' 8-103.11 before:

(A) Smoking FOOD as a method of FOOD preservation rather

than as a method of flavor enhancement; (B) Curing FOOD; (C) Using FOOD ADDITIVES or adding components such as

vinegar: (1) As a method of FOOD preservation rather than as a

method of flavor enhancement, or (2) To render a FOOD so that it is not POTENTIALLY

HAZARDOUS (TIME/TEMPERATURE CONTROL OF SAFETY FOOD); (D) Packaging FOOD using a REDUCED OXYGEN PACKAGING

method except as specified under ' 3-502.12 where a barrier to Clostridium botulinum in addition to refrigeration exists;

(E) Operating a MOLLUSCAN SHELLFISH life-support system

display tank used to store and display shellfish that are offered for human consumption;

(F) Custom processing animals that are for personal use as

FOOD and not for sale or service in a FOOD ESTABLISHMENT; (G) Preparing FOOD by another method that is determined by

the REGULATORY AUTHORITY to require a VARIANCE; or (H) Sprouting seeds or beans.

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Clostridium botulinum and Listeria monocytogenes Controls

3-502.12 Reduced Oxygen Packaging, Criteria.* (A) Except for a FOOD ESTABLISHMENT that obtains a VARIANCE as specified under ' 3-502.11 and except as specified under ¶¶ (C) and (E) and as specified in ¶ (D) of this section, a FOOD ESTABLISHMENT that PACKAGES POTENTIALLY HAZARDOUS FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) using a REDUCED OXYGEN PACKAGING method shall ensure that there are at least two barriers in place to control the growth and toxin formation of Clostridium botulinum and the growth of Listeria monocytogenes.

(B) A FOOD ESTABLISHMENT that PACKAGES POTENTIALLY HAZARDOUS

FOOD (TIME/TEMPERATURE CONTROL FOR SAFETY FOOD) using a REDUCED OXYGEN PACKAGING method shall have a HACCP PLAN that contains the information specified under ¶ 8-201.14(D) and that:

(1) Identifies the FOOD to be PACKAGED; (2) Except as specified under ¶¶ (C) and (E) and as specified

in ¶ (D) of this section, requires that the PACKAGED FOOD shall be maintained at 5°C (41°F) or less and meet at least one of the following criteria:

(a) Has an AW of 0.91 or less, (b) Has a PH of 4.6 or less, (c) Is a MEAT or POULTRY product cured at a FOOD

PROCESSING PLANT regulated by the USDA using substances specified in 9 CFR 424.21, Use of food ingredients and sources of radiation, and is received in an intact PACKAGE, or

(d) Is a FOOD with a high level of competing organisms

such as raw MEAT or raw POULTRY; (3) Describes how the PACKAGE shall be prominently and

conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to:

(a) Maintain the FOOD at 5oC (41oF) or below, and (b) Discard the FOOD if within 14 calendar days of its

PACKAGING it is not served for on-PREMISES consumption, or

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consumed if served or sold for off-PREMISES consumption; (4) Limits the refrigerated shelf life to no more than 14

calendar days from PACKAGING to consumption, except the time the product is maintained frozen, or the original manufacturer’s “sell by” or “use by” date, whichever occurs first;

(5) Includes operational procedures that: (a) Prohibit contacting FOOD with bare hands, (b) Identify a designated work area and the method by

which: (i) Physical barriers or methods of separation of raw

FOODS and READY-TO-EAT FOODS minimize cross contamination, and

(ii) Access to the processing EQUIPMENT is limited to

responsible trained personnel familiar with the potential HAZARDS of the operation, and

(c) Delineate cleaning and SANITIZATION procedures for

FOOD-CONTACT SURFACES; and (6) Describes the training program that ensures that the

individual responsible for the REDUCED OXYGEN PACKAGING operation understands the:

(a) Concepts required for a safe operation, (b) EQUIPMENT and facilities, and (c) Procedures specified under Subparagraph (B)(5) of this

section and ¶ 8-201.14(D). Fish (C) Except for FISH that is frozen before, during, and after

PACKAGING, a FOOD ESTABLISHMENT may not PACKAGE FISH using a REDUCED OXYGEN PACKAGING method.

Cook-Chill or Sous Vide

(D) Except as specified under ¶ (C) of this section, a FOOD ESTABLISHMENT may package FOOD using a cook-chill or sous vide process without obtaining a VARIANCE if:

(1) The FOOD ESTABLISHMENT implements a HACCP PLAN that

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contains the information as specified under ¶ 8-201.14(D); (2) The FOOD is: (a) Prepared and consumed on the PREMISES, or prepared

and consumed off the PREMISES but within the same business entity with no distribution or sale of the bagged product to another business entity or the CONSUMER,

(b) Cooked to heat all parts of the FOOD to a temperature

and for a time as specified under § 3-401.11, (c) Protected from contamination after cooking as specified

under Part 3-3, (d) Placed in a package or bag with an oxygen barrier

before cooking, or placed in a PACKAGE or bag immediately after cooking and before reaching a temperature below 57°C (135°F),

(e) Except for frozen FOOD that is not shelf life restricted,

cooled to 5°C (41°F) in the PACKAGE or bag as specified under § 3-501.14 and then cooled to 1°C (34°F) or less within 48 hours of reaching 5°C (41°F), and:

(i) Held at 1°C (34°F) and consumed or discarded within

30 days after the date of preparation, or (ii) If removed from a storage unit that maintains a 1°C

(34°F) FOOD temperature, held at 5°C (41°F) or less for no more than 72 hours before consumption.

(f) Held in a refrigeration unit that is equipped with an

electronic system that continuously monitors time and temperature and is visually examined for proper operation twice daily,

(g) If transported off-site to a satellite location of the same

business entity, equipped with verifiable electronic monitoring devices to ensure that times and temperatures are monitored during transportation, and

(h) Labeled with the product name and the date PACKAGED;

and (3) The records required to confirm that cooling and cold

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holding refrigeration time/temperature parameters are required as part of the HACCP PLAN, are maintained and are:

(a) Made available to the REGULATORY AUTHORITY upon

request, and (b) Held for 6 months; and (4) Written operational procedures as specified under

Subparagraph (B)(5) of this section and a training program as specified under Subparagraph (B)(6) of this section are implemented.

Cheese (E) A FOOD ESTABLISHMENT may PACKAGE cheese using a REDUCED

OXYGEN PACKAGING method without obtaining a VARIANCE if it: (1) Limits the cheeses PACKAGED to those that are

commercially manufactured in a FOOD PROCESSING PLANT with no ingredients added in the FOOD ESTABLISHMENT and that meet the Standards of Identity as specified in 21 CFR 133.150 Hard cheeses, 21 CFR 133.169 Pasteurized process cheese or 21 CFR 133.187 Semisoft cheeses;

(2) Has a HACCP PLAN that contains the information specified

under ¶ 8-201.14(D); (3) Except as specified under Subparagraphs (B)(2), (B)(3)(b),

and (B)(4), complies with ¶ (B) of this section; (4) Labels the PACKAGE on the principal display panel with a

“use by” date that does not exceed 30 days or the original manufacturer’s “sell by” or “use by” date, whichever occurs first; and

(5) Discards the REDUCED OXYGEN PACKAGED cheese if it is not

sold for off-PREMISES consumption or consumed within 30 calendar days of its PACKAGING.

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3-6 FOOD IDENTITY, PRESENTATION, AND ON-PREMISES LABELING

Subparts

3-601 Accurate Representation 3-602 Labeling

3-603 Consumer Advisory

Accurate Representation

3-601.11 Standards of Identity.

PACKAGED FOOD shall comply with standard of identity requirements in 21 CFR 131-169 and 9 CFR 319 Definitions and standards of identity or composition, and the general requirements in 21 CFR 130 – Food Standards: General and 9 CFR 319 Subpart A – General.

3-601.12 Honestly Presented. (A) FOOD shall be offered for human consumption in a way that

does not mislead or misinform the CONSUMER. (B) FOOD or COLOR ADDITIVES, colored overwraps, or lights may

not be used to misrepresent the true appearance, color, or quality of a FOOD.

Labeling 3-602.11 Food Labels.

(A) FOOD PACKAGED in a FOOD ESTABLISHMENT, shall be labeled as specified in LAW, including 21 CFR 101 - Food labeling, and 9 CFR 317 Labeling, marking devices, and containers.

(B) Label information shall include: (1) The common name of the FOOD, or absent a common

name, an adequately descriptive identity statement; (2) If made from two or more ingredients, a list of ingredients

in descending order of predominance by weight, including a declaration of artificial color or flavor and chemical preservatives, if contained in the FOOD;

(3) An accurate declaration of the quantity of contents;

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(4) The name and place of business of the manufacturer,

packer, or distributor; and (5) The name of the FOOD source for each MAJOR FOOD

ALLERGEN contained in the FOOD unless the FOOD source is already part of the common or usual name of the respective ingredient (Effective January 1, 2006).

(6) Except as exempted in the Federal Food, Drug, and

Cosmetic Act § 403(Q)(3) - (5), nutrition labeling as specified in 21 CFR 101 - Food Labeling and 9 CFR 317 Subpart B Nutrition Labeling.

(7) For any salmonid FISH containing canthaxanthin as a

COLOR ADDITIVE, the labeling of the bulk FISH container, including a list of ingredients, displayed on the retail container or by other written means, such as a counter card, that discloses the use of canthaxanthin.

(C) Bulk FOOD that is available for CONSUMER self-dispensing

shall be prominently labeled with the following information in plain view of the CONSUMER:

(1) The manufacturer's or processor's label that was provided

with the FOOD; or (2) A card, sign, or other method of notification that includes

the information specified under Subparagraphs (B)(1), (2), and (5) of this section.

(D) Bulk, unPACKAGED FOODS such as bakery products and

unPACKAGED FOODS that are portioned to CONSUMER specification need not be labeled if:

(1) A health, nutrient content, or other claim is not made; (2) There are no state or local LAWS requiring labeling; and (3) The FOOD is manufactured or prepared on the PREMISES of

the FOOD ESTABLISHMENT or at another FOOD ESTABLISHMENT or a FOOD PROCESSING PLANT that is owned by the same PERSON and is regulated by the FOOD regulatory agency that has jurisdiction.

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3-602.12 Other Forms of Information. (A) If required by LAW, CONSUMER warnings shall be provided.

(B) FOOD ESTABLISHMENT or manufacturers' dating information on

FOODS may not be concealed or altered. Consumer Advisory

3-603.11 Consumption of Animal Foods that are Raw, Undercooked, or Not Otherwise Processed to Eliminate Pathogens.*

(A) Except as specified in ¶ 3-401.11(C) and Subparagraph 3-401.11(D)(3) and under ¶ 3-801.11(D), if an animal FOOD such as beef, EGGS, FISH, lamb, milk, pork, POULTRY, or shellfish is served or sold raw, undercooked, or without otherwise being processed to eliminate pathogens, either in READY-TO-EAT form or as an ingredient in another READY-TO-EAT FOOD, the PERMIT HOLDER shall inform CONSUMERS of the significantly increased RISK of consuming such FOODS by way of a DISCLOSURE and REMINDER, as specified in ¶¶ (B) and (C) of this section using brochures, deli case or menu advisories, label statements, table tents, placards, or other effective written means.

(B) DISCLOSURE shall include:

(1) A description of the animal-derived FOODS, such as “oysters on the half shell (raw oysters),” “raw-EGG Caesar salad,” and “hamburgers (can be cooked to order);” or

(2) Identification of the animal-derived FOODS by asterisking

them to a footnote that states that the items are served raw or undercooked, or contain (or may contain) raw or undercooked ingredients.

(C) REMINDER shall include asterisking the animal-derived FOODS

requiring DISCLOSURE to a footnote that states: (1) Regarding the safety of these items, written information is

available upon request; (2) Consuming raw or undercooked MEATS, POULTRY, seafood,

shellfish, or EGGS may increase your RISK of foodborne illness; or

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(3) Consuming raw or undercooked MEATS, POULTRY, seafood, shellfish, or EGGS may increase your RISK of foodborne illness, especially if you have certain medical conditions.

3-7 CONTAMINATED FOOD

Subpart

3-701 Disposition

Disposition 3-701.11 Discarding or Reconditioning Unsafe,

Adulterated, or Contaminated Food.* (A) A FOOD that is unsafe, ADULTERATED, or not honestly presented as specified under § 3-101.11 shall be discarded or reconditioned according to an APPROVED procedure.

(B) FOOD that is not from an APPROVED source as specified under

§§ 3-201.11 - .17 shall be discarded. (C) READY-TO-EAT FOOD that may have been contaminated by an

EMPLOYEE who has been RESTRICTED or EXCLUDED as specified under § 2-201.12 shall be discarded.

(D) FOOD that is contaminated by FOOD EMPLOYEES, CONSUMERS,

or other PERSONS through contact with their hands, bodily discharges, such as nasal or oral discharges, or other means shall be discarded.

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3-8 SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS

Subpart

3-801 Additional Safeguards

Additional Safeguards

3-801.11 Pasteurized Foods, Prohibited Re-Service, and Prohibited Food*

In a FOOD ESTABLISHMENT that serves a HIGHLY SUSCEPTIBLE POPULATION:

(A) The following criteria apply to JUICE: (1) For the purposes of this paragraph only, children who

are age 9 or less and receive FOOD in a school, day care setting, or similar facility that provides custodial care are included as HIGHLY SUSCEPTIBLE POPULATIONS;

(2) PrePACKAGED JUICE or a prePACKAGED BEVERAGE

containing JUICE, that bears a warning label as specified in 21 CFR, 101.17(g) Food labeling, warning, notice, and safe handling statements, Juices that have not been specifically processed to prevent, reduce, or eliminate the presence of pathogens, or a PACKAGED JUICE or BEVERAGE containing JUICE, that bears a warning label as specified under ¶ 3-404.11(B) may not be served or offered for sale; and

(3) UnPACKAGED JUICE that is prepared on the premises for

service or sale in a READY-TO-EAT form shall be processed under a HACCP PLAN that contains the information specified under ¶¶ 8-201.14(B) - (E) and as specified in 21 CFR Part 120 – Hazard Analysis and Critical Control Point (HACCP) Systems, Subpart B Pathogen Reduction, 120.24 Process controls.

(B) Pasteurized EGGS or EGG PRODUCTS shall be substituted

for raw EGGS in the preparation of: (1) FOODS such as Caesar salad, hollandaise or

Béarnaise sauce, mayonnaise, meringue, EGGnog, ice cream, and EGG-fortified BEVERAGES, and

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(2) Except as specified in ¶ (F) of this section, recipes in

which more than one EGG is broken and the EGGS are combined;

(C) The following FOODS may not be served or offered for sale

in a READY-TO-EAT form: (1) Raw animal FOODS such as raw FISH, raw-

marinated FISH, raw MOLLUSCAN SHELLFISH, and steak tartare,

(2) A partially cooked animal FOOD such as lightly

cooked FISH, rare MEAT, soft-cooked EGGS that are made from raw EGGS, and meringue; and

(3) Raw seed sprouts. (D) FOOD EMPLOYEES may not contact READY-TO-EAT FOOD as

specified under ¶¶ 3-301.11(B) and (D). (E) Time only, as the public health control as specified under

§ 3-501.19(D), may not be used for raw EGGS. (F) Subparagraph (B)(2) of this section does not apply if: (1) The raw EGGS are combined immediately before

cooking for one CONSUMER=S serving at a single meal, cooked as specified under Subparagraph 3-401.11(A)(1), and served immediately, such as an omelet, soufflé, or scrambled EGGS;

(2) The raw EGGS are combined as an ingredient

immediately before baking and the EGGS are thoroughly cooked to a READY-TO-EAT form, such as a cake, muffin, or bread; or

(3) The preparation of the food is conducted under a

HACCP PLAN that: (a) Identifies the FOOD to be prepared, (b) Prohibits contacting READY-TO-EAT FOOD with bare

hands,

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(c) Includes specifications and practices that ensure: (i) Salmonella Enteritidis growth is controlled

before and after cooking, and (ii) Salmonella Enteritidis is destroyed by cooking

the EGGS according to the temperature and time specified in Subparagraph 3-401.11(A)(2),

(d) Contains the information specified under

¶ 8-201.14(D) including procedures that: (i) Control cross contamination of READY-

TO-EAT FOOD with raw EGGS, and (ii) Delineate cleaning and SANITIZATION

procedures for FOOD-CONTACT SURFACES, and

(e) Describes the training program that ensures that

the FOOD EMPLOYEE responsible for the preparation of the FOOD understands the procedures to be used.

Re-service of Food

(G) Except as specified in paragraph (H) of this section, FOODmay be re-served as specified under Subparagraph 3-306.14(B)(1) and (2).

Prohibited Re-service of Food

(H) FOOD may not be re-served under the following conditions:

(1) Any FOOD served to patients or clients who are under contact precautions in medical isolation or quarantine, or protective environment isolation may not be re-served to others outside.

(2) Packages of FOOD from any patients, clients, or other

CONSUMERS should not be re-served to PERSONS in protective environment isolation.